FDA Pledges No Regulation, Tax of Consumer mHealth Apps

April 10, 2013
The Energy and Commerce Subcommittee, comprised of by the U.S. House of Representatives members, conclude its hearings on health information technologies, specifically potential regulations and taxes on smartphones, tablets, and mobile apps. In the final day of testimony, Christy Foreman, representative of the Food and Drug Administration (FDA), said the agency’s policy on mobile medical apps will not include the regulation of consumers’ smartphones or tablets.

The Energy and Commerce Subcommittee, comprised of by the U.S. House of Representatives members, conclude its hearings on health information technologies, specifically potential regulations and taxes on smartphones, tablets, and mobile apps. In the final day of testimony,  Christy Foreman, representative of the Food and Drug Administration (FDA), said the agency’s policy on mobile medical apps will not include the regulation of consumers’ smartphones or tablets.

“Just as importantly as what our policy proposes is what our policy does not propose. It would not regulate the sale or general consumer use of smartphones or tablets. It would not consider entities that exclusively distribute mobile medical apps, such as the ‘iTunes App store’ or the ‘Android market,’ to be medical device manufacturers,” Foreman, who is the FDA's director of the Office of Device Evaluation in the Center for Devices and Radiological Health, said at the hearing.

In addition, she said the FDA would not consider mobile platform manufacturers to be medical device manufacturers just because their mobile platform could be used to run a mobile medical app regulated by FDA. Nor would the FDA require mobile medical app developers to seek Agency re-evaluation for minor, iterative product changes. And, it would not apply to mobile apps that perform the functionality of an electronic health record (EHR) system or personal health record system.

Energy and Commerce Committee Chairman Fred Upton (R-MI) was happy with this clarity. He said it was a win for both consumers and innovators. “We can only hope FDA sticks to its word and continues to allow doctors and developers to operate in an environment that promotes innovation with an eye toward improving patient care,” Upton said.

Earlier in the week, advocates for the mobile app community expressed concern over the FDA not finalizing the rule that they say could apply to apps, smartphones, and tablets.

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